Therapy of Age-related Macular Degeneration

NCT ID: NCT05222997

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-04-30

Brief Summary

People with the disease age-related macular degeneration (AMD) are treated with the Medical Eye Trainer (MET) system to improve their vision. The training is carried out over 2 months.

Detailed Description

Age-related macular degeneration (AMD) is a widespread eye disease worldwide. According to the Gutenberg Health Study, about 7000000 people in Germany suffer from it. The numbers for Austria are to be assumed with 700000 due to the smaller population. There are two different forms of AMD, the wet form with 15% and the dry form with 85%. Both types have a high risk of rapid development of significant visual impairment. For the dry form of the disease there are currently only a few therapeutic options. The main one is the nutritional supplement therapy. This treatment can only reduce the progression of deterioration in 10% of affected individuals, but there is a significant side effect profile. Thus, the question arose for completely different treatment approaches. For this reason, the Medical Eye Trainer (MET) was developed. This is a training device which can easily be used in self application. The purpose of this new therapy is not to try to cure AMD. Instead, the eye and brain are trained to better cope with the disease. In a first study on 17 eyes, 11 cases even showed an improvement of the visual performance, the remaining 6 cases showed a stable situation. In no case did a deterioration occur. Thus, for the first time, it was possible not only to slow down this disease, but even to achieve an improvement. In a second study with a planned number of 150 persons, this positive effect will be further investigated. A calculation with G*Power, based on the results of the first study, results in an optimal number of 150 examinations.

The participants will be examined in the hospital Ried im Innkreis and treated by MET. No additional measures are required for the study besides the usual eye examinations in AMD.

The study is open to individuals with dry AMD, regardless of age. Exclusion criteria are wet AMD, epilepsy and double vision. Other eye diseases are not a problem.

The diagnosis is additionally confirmed by an examination of the ocular fundus with an Optical Coherence Tomography (OCT). As an essential factor of the severity of the disease, the visual performance for distance (5-6m) and for near (40cm) is determined.

Participants need a mobile electronic device with the operating system Apple IOS® or Android®. The MET training system in the form of software will be provided for the duration of the study. The therapy is performed daily by the patient him/herself and lasts 90 seconds per eye. A success control is planned after two months. The above mentioned examinations will be repeated.

The MET has a CE-approval in the sense of MPG class 1. This study will be performed according to the Helsinki criteria.

Conditions

Age-Related Macular Degeneration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age-related macular degeneration

Exclusion Criteria

• Epilepsy
• Double vision

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Hörantner

OTHER

Sponsor Role: lead

Responsible Party

Robert Hörantner

Head of Ophthalmology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

BHS Ried

Ried im Innkreis, Upperaustria, Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Robert Hörantner, MD

Role: primary

robert.hoerantner@bhs.at

00437752602

Lucie Junger, MD

Role: backup

lucie.junger@bhs.at

00437752603

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1241/2021

Identifier Type: -

Identifier Source: org_study_id